Generics, biosimilars, enantiomers and me-toos
The term “generic” applies to products containing mostly small molecule chemical active substances, usually produced by chemical synthesis. EU legislation describes a generic product as a product which has the same active substance in the same amount as t
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Medicines Agency, London, UK ofClinical Pharmacology, Medical University Vienna, Vienna, Austria
2 Department
1 Generics The term "generic" applies to products containing mostly small molecule chemical active substances, usually produced by chemical synthesis. EU legislation describes a generic product as a product which has the same active substance in the same amount as the originator's product (the reference product), the same pharmaceutical form, and whose bioequivalence with the reference product has been demonstrated by appropriate bioavailability studies [1]. "Innovative" products in most countries of the world are rewarded and protected from competition in a number of ways, but they are not allowed to keep the market to themselves forever. Generic medicines are basically copies of these innovative medicines which were once new but which have been marketed for several years with proven satisfactory efficacy and safety. The passage of time (10 years in most EU Member States) transforms innovative medicines with new active substances into established medicines, and opens the door to generic competition. Current EU and US legislation imposes a large regulatory burden on companies developing new molecules - they must provide evidence of satisfactory quality, efficacy and safety, in particular complete details of all toxicology, pharmacology, and clinical trials. In compensation, they are allowed to protect their intellectual property, and to enjoy some measure of regulatory protection from generic competition. Generic medicines are not required to repeat all of these toxicology and clinical studies when the innovator's product has shown many years of safe and effective use - indeed there is a sense in which it may be regarded as unethical to do so. This is also the situation in the USA and in many other countries worldwide . On the other hand, given this minimal clinical development in the case of a generic, it is the responsibility of the regulatory
• The views expressed in this chapter are the personal views of the authors and may not be used or quoted as being made on behalf of, or reflecting the position of, any national competent authority, the European Medicines Agency (EMA) or one of its committees or working parties.
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Chapter 23: Generics, biosimilars, enantiomers and me-toos
authorities to ensure that the generic product is equivalent to the originator's product in all important respects, and to assure patients and prescribers that there is no significant difference between the two products in the clinic. In the EU, the term "essentially similar" has been used to describe the relationship between the two, and as expected, the precise meaning of this term has been debated in the courts over many years. In brief, one of the most important ways of providing this assurance is to demonstrate that the generic product is bioequivalent to the reference product. Since generic companies are not required to repeat the large multicentre clinical trials of the innovator, and instead are able to rest mainly
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